WO2003096903A1 - Sensor unit and method for sensing a blood related parameter and system including such a sensor unit - Google Patents

Sensor unit and method for sensing a blood related parameter and system including such a sensor unit Download PDF

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Publication number
WO2003096903A1
WO2003096903A1 PCT/SE2003/000784 SE0300784W WO03096903A1 WO 2003096903 A1 WO2003096903 A1 WO 2003096903A1 SE 0300784 W SE0300784 W SE 0300784W WO 03096903 A1 WO03096903 A1 WO 03096903A1
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WO
WIPO (PCT)
Prior art keywords
sensor unit
access device
blood
bloodstream
sensor
Prior art date
Application number
PCT/SE2003/000784
Other languages
French (fr)
Inventor
Bo G. Danielson
Dick Persson
Original Assignee
Hemapure Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hemapure Ab filed Critical Hemapure Ab
Priority to AU2003232703A priority Critical patent/AU2003232703A1/en
Priority to EP03752960A priority patent/EP1509131B1/en
Priority to DE60323633T priority patent/DE60323633D1/en
Priority to US10/514,635 priority patent/US20050131305A1/en
Priority to JP2004504908A priority patent/JP2005529642A/en
Publication of WO2003096903A1 publication Critical patent/WO2003096903A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/681—Wristwatch-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6865—Access ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6876—Blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879—Means for maintaining contact with the body
    • A61B5/6884—Clamps or clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0008—Temperature signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0267—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body comprising sensors or electrical contacts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics

Definitions

  • Sensor unit and method for sensing a blood related parameter and system including such a sensor unit
  • the invention concerns a sensor unit for sensing a blood related parameter in a bloodstream of a human or an animal. It also concerns a method for monitoring the function of a bloodstream access device and a blood parameter sensor system including such a sensor unit.
  • US-A-5 120 313 discloses a method for measuring blood pressure in an animal or human using a percutaneous access port .
  • This access port includes a base assembly which is intended to be implanted into the animal or human and comprises an inlet port which is adapted to be connected to a selected organ in order to provide communication with a fluid chamber inside the base assembly.
  • a transducer inside the fluid chamber of the base assembly is adapted to detect the pressure of the fluid so as to provide a signal indicative of the blood pressure of the human or the animal.
  • the described arrangement is equipped with a pump for continuously flushing the system including a catheter for connection to the bloodstream of the human or the animal in order to prevent formation of blood clots. Altogether the described arrangement is an insecure, complicated, limited and expensive solution which appears to be mainly intended for use in animals in connection with medical research.
  • the inventive sensor unit provides for easy application in or on a bloodstream access device and guarantees that the sensor element is operative with respect of a continuous blood flow, thus guaranteeing that sensing of the blood related parameter is carried out accurately.
  • a bloodstream access device which preferably is implanted for permanent use. Normally such devices are implanted so as to allow blood treatment such as blood filtering in case of patients with a renal failure diagnosis. According to this aspect of the invention such a device is used as part of the sensor system besides its normal use for blood treatment.
  • a preferred bloodstream access device is previously known from WO 99/20338 (Hemapure AB) . It is preferred that a lid member being included in the sensor unit of the present invention is adapted to be applied to a bloodstream access device according to that document in a manner which is thoroughly described therein.
  • Allowing a continuous blood flow during operation of the sensor element avoids formation of clots etc. and contributes to the sensor unit according to the invention being a long life solution.
  • An inventive method provides for monitoring the function of the bloodstream access device.
  • the blood temperature is sensed in a channel which allows a continuous blood flow passing between an artery side and a vein side of the bloodstream access device.
  • the sensed value is used as an indication of the blood flow through the bloodstream access device.
  • Low flow and low temperature might indicate malfunction of the access device for various reasons and should at least trigger a control of the device by skilled personnel .
  • Fig. la shows a bloodstream access device for use in connection with a system according to the invention
  • Figs. 2a and 2b show an arrangement including a bloodstream access device with attached sensor unit according to the invention
  • Fig. 3a and 3b show an alternative sensor unit
  • Fig. 4 shows a system including an inventive sensor unit in respect of a human.
  • a bloodstream access device 1 having nipples 2 and 2' for connection to an artery and a vein of a human or an animal.
  • Channels 3 and 3' interconnect the nipples with a flat or curved interface surface 4 which is intended for connection to a connection device belonging to an external circuit.
  • a connection device belonging to an external circuit.
  • Such a circuit could include an artificial kidney.
  • the interface is co-operating with a lid between blood treatments, said lid including a channel for allowing a continuous flow between the artery and the vein side through the channels 3 and 3' .
  • the device 1 is intended for permanent implantation into a human or an animal and includes means for allowing ingrowth of body tissue for stabilising purposes.
  • the bloodstream access device 1 in Fig. 1 is shown in a view from the right in Fig. 1 carrying a sensor unit 5 which is shown in a section.
  • the sensor unit 5 co-operates with the bloodstream access device to that extent that it provides sealing co-operation between a sealing surface 6 and the surface of the interface 4 of the bloodstream access device 1.
  • the sensor unit 5 is thus positioned and fixed on the bloodstream access device in a manner which is described in the above-mentioned WO document.
  • the sensor unit 5 has a channel portion 7 which is intended to interconnect the channels 3 and 3' of the bloodstream access device 1 so as to allow a continuous blood flow through the device with the applied sensor unit 5.
  • the channel 7 is limited by a wall including a sensor element 8 comprising a sensor layer 9 which comprises the inner wall portion of that part of the channel portion 7.
  • the sensor element 8 includes a translucent protective layer 10 which protects the sensor layer 9 from being affected from outside mechanical influences as well as, in certain applications, provides a certain thermal insulation so as not to cool down the blood streaming through the channel 7.
  • the sensor layer 9 includes preferably liquid crystals which are sensitive to the parameter which at present is intended to be sensed. It may thus for example be temperature sensitive or sensitive to a defined substance in the bloodstream such as insulin or glucose. As is per se known, the sensor layer may be of a kind which changes colour so as provide a visual indication of the parameter level, be it temperature, concentration etc., of the blood being present inside the channel 7.
  • Temperature indication may in turn be used as a measurement of the flow through the channel 7. I.e. in principle, high flow results in high temperature; low flow results in lower temperature. Flow indication in turn may be used for monitoring the function of the bloodstream access device and absence of clots etc. However, temperature indication could also be used for monitoring the certain ill-health conditions of the patient. An ideal temperature might be for example 35°C and higher or lower temperatures might indicate some kind of problem.
  • the indication could be used as a warning or as a trigger for introducing medication into the patient.
  • the sensor layer includes sensor elements that are indicative of the concentration of a specific substance in the bloodstream, this may be indicated similarly, that is with liquid crystals which have the capability to change colour or in any other per se known manner.
  • Fig. 2b shows the bloodstream access device 1 from above with a fastened sensor unit 5.
  • the sensor element 8 is shown as an oblong element in the centre of the sensor unit 5.
  • the sensor element 8 is surrounded by a surface 20 having a colour scale.
  • easy comparison with the present colour of the sensor element 8 is enabled. This makes it possible to have a quick indication on the temperature and thus the function of the device 1 or, at occasions, the concentration level etc. prevailing inside channel 7.
  • a second embodiment of a sensor unit 11 is shown in fig 3a.
  • the sensor unit is provided with snap wings 14, and pressing portions 15 on holding means 17. Further, locking elements or shoulders 18 are used for positioning the sensor unit 11 on a bloodstream access device 1 (Fig. 1) .
  • An oblong sensor element 16 is positioned centrally and with an acute angle with respect to a longitudinal axis of the sensor unit 11. At the sides of the sensor element 16, there are indicated two areas 19 which may be coloured in scales so as to provide easy indication of flow, temperature, concentration etc. etc.
  • Fig. 3b shows the sensor unit 11 in a longitudinal section wherein the curved sensor element 16 contributes to limit a channel 13, which corresponds to the channel 7 of the sensor unit 5 in Fig. 2a.
  • the invention may be modified further and for example the sensor units 5 and 11, which in practice are lid members for co-operation with the bloodstream access device, may be connected to outside equipment for indicating sensed temperature, flow concentration etc.
  • This is indicated in fig 4, which shows a system including an inventive sensor unit in respect of a human.
  • the lid member may be connected, for example over an electric wire 21 or wireless, with a wrist carried indicator 22 resembling a wrist-watch.
  • an inventive sensor unit may be connected to an insulin pump 23 for introducing insulin into the body of the patient.
  • a simple external device may be a warning indicator such as a buzzer, a beeper or a lamp, indicating malfunction or parameter levels below a predetermined value.
  • blood temperature, blood flow, blood-pressure, level of biochemical substances such as glucose, insulin, urea may be subject to being sensed by adapted sensor elements of a sensor unit according to the invention. Further modifications may include other per se known sensor elements; use in connection with other types of bloodstream access devices; and connections to other kinds of indicators and external equipment .

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Pathology (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Vascular Medicine (AREA)
  • Optics & Photonics (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)

Abstract

A sensor unit (5) and a method for sensing a blood related parameter in a bloodstream of a human or an animal, including sensing the blood related parameter(s) in a channel (7) of a lid member for a main body of a bloodstream access device (1) which channel allows a continuous blood flow passing between an artery side and a vein side of the bloodstream access device (1). The invention also concerns a method for monitoring the function of a bloodstream access device and a blood parameter sensor system.

Description

Sensor unit and method for sensing a blood related parameter and system including such a sensor unit
Field of the invention
The invention concerns a sensor unit for sensing a blood related parameter in a bloodstream of a human or an animal. It also concerns a method for monitoring the function of a bloodstream access device and a blood parameter sensor system including such a sensor unit.
Description of Prior Art Various devices are previously known for sensing various parameters in the bloodstream of a human. The most common arrangement for measuring such parameters is by introducing a catheter including a sensor element into body tissue of the patient. This procedure however is somewhat problematic, since the sensor element may be positioned outside an intended blood vessel which can result in erroneous measurements. Another drawback is that it is often necessary to punch the patient's skin at regular intervals in order to gain proper access to the patient's bloodstream, since this solution is not suitable for permanent use.
US-A-5 120 313 discloses a method for measuring blood pressure in an animal or human using a percutaneous access port . This access port includes a base assembly which is intended to be implanted into the animal or human and comprises an inlet port which is adapted to be connected to a selected organ in order to provide communication with a fluid chamber inside the base assembly. A transducer inside the fluid chamber of the base assembly is adapted to detect the pressure of the fluid so as to provide a signal indicative of the blood pressure of the human or the animal. The described arrangement is equipped with a pump for continuously flushing the system including a catheter for connection to the bloodstream of the human or the animal in order to prevent formation of blood clots. Altogether the described arrangement is an insecure, complicated, limited and expensive solution which appears to be mainly intended for use in animals in connection with medical research.
Aim and most important features of the invention
It is an aim of this invention to provide a solution to the prior art problems and in particular to provide a secure, inexpensive and easy handled sensor arrangement.
This aim is achieved in a sensor unit as above according to the features of the characterising portion of claim 1.
The inventive sensor unit provides for easy application in or on a bloodstream access device and guarantees that the sensor element is operative with respect of a continuous blood flow, thus guaranteeing that sensing of the blood related parameter is carried out accurately.
It is an advantage to use a bloodstream access device which preferably is implanted for permanent use. Normally such devices are implanted so as to allow blood treatment such as blood filtering in case of patients with a renal failure diagnosis. According to this aspect of the invention such a device is used as part of the sensor system besides its normal use for blood treatment.
One example of a preferred bloodstream access device is previously known from WO 99/20338 (Hemapure AB) . It is preferred that a lid member being included in the sensor unit of the present invention is adapted to be applied to a bloodstream access device according to that document in a manner which is thoroughly described therein.
Allowing a continuous blood flow during operation of the sensor element avoids formation of clots etc. and contributes to the sensor unit according to the invention being a long life solution.
An inventive method provides for monitoring the function of the bloodstream access device. Hereby the blood temperature is sensed in a channel which allows a continuous blood flow passing between an artery side and a vein side of the bloodstream access device. The sensed value is used as an indication of the blood flow through the bloodstream access device. Low flow and low temperature might indicate malfunction of the access device for various reasons and should at least trigger a control of the device by skilled personnel .
Further advantages are achieved with respect to further aspects of the invention and will be explained in the following detailed description.
Brief description of drawings
The invention will now be described in more detail at the background of preferred embodiments and with reference to the drawings, wherein:
Fig. la shows a bloodstream access device for use in connection with a system according to the invention,
Figs. 2a and 2b show an arrangement including a bloodstream access device with attached sensor unit according to the invention, Fig. 3a and 3b show an alternative sensor unit, and
Fig. 4 shows a system including an inventive sensor unit in respect of a human.
Description of embodiments In Fig. 1 a bloodstream access device 1 is shown having nipples 2 and 2' for connection to an artery and a vein of a human or an animal. Channels 3 and 3' interconnect the nipples with a flat or curved interface surface 4 which is intended for connection to a connection device belonging to an external circuit. Such a circuit could include an artificial kidney. The interface is co-operating with a lid between blood treatments, said lid including a channel for allowing a continuous flow between the artery and the vein side through the channels 3 and 3' .
Fixing the different lids and connection devices onto the bloodstream access device is not part of the invention, but for understanding reference is made to the above mentioned document WO 99/20338. The device 1 is intended for permanent implantation into a human or an animal and includes means for allowing ingrowth of body tissue for stabilising purposes.
In Fig. 2a the bloodstream access device 1 in Fig. 1 is shown in a view from the right in Fig. 1 carrying a sensor unit 5 which is shown in a section. The sensor unit 5 co-operates with the bloodstream access device to that extent that it provides sealing co-operation between a sealing surface 6 and the surface of the interface 4 of the bloodstream access device 1. The sensor unit 5 is thus positioned and fixed on the bloodstream access device in a manner which is described in the above-mentioned WO document. Further, the sensor unit 5 has a channel portion 7 which is intended to interconnect the channels 3 and 3' of the bloodstream access device 1 so as to allow a continuous blood flow through the device with the applied sensor unit 5. At the top the channel 7 is limited by a wall including a sensor element 8 comprising a sensor layer 9 which comprises the inner wall portion of that part of the channel portion 7.
Further, the sensor element 8 includes a translucent protective layer 10 which protects the sensor layer 9 from being affected from outside mechanical influences as well as, in certain applications, provides a certain thermal insulation so as not to cool down the blood streaming through the channel 7.
The sensor layer 9 includes preferably liquid crystals which are sensitive to the parameter which at present is intended to be sensed. It may thus for example be temperature sensitive or sensitive to a defined substance in the bloodstream such as insulin or glucose. As is per se known, the sensor layer may be of a kind which changes colour so as provide a visual indication of the parameter level, be it temperature, concentration etc., of the blood being present inside the channel 7.
Temperature indication may in turn be used as a measurement of the flow through the channel 7. I.e. in principle, high flow results in high temperature; low flow results in lower temperature. Flow indication in turn may be used for monitoring the function of the bloodstream access device and absence of clots etc. However, temperature indication could also be used for monitoring the certain ill-health conditions of the patient. An ideal temperature might be for example 35°C and higher or lower temperatures might indicate some kind of problem.
Taken more generally, the indication could be used as a warning or as a trigger for introducing medication into the patient.
In case the sensor layer includes sensor elements that are indicative of the concentration of a specific substance in the bloodstream, this may be indicated similarly, that is with liquid crystals which have the capability to change colour or in any other per se known manner.
Fig. 2b shows the bloodstream access device 1 from above with a fastened sensor unit 5. The sensor element 8 is shown as an oblong element in the centre of the sensor unit 5.' In case of liquid crystal material having the provision to change colour as ' a response to sensed parameter values, it is preferred that the sensor element 8 is surrounded by a surface 20 having a colour scale. Hereby easy comparison with the present colour of the sensor element 8 is enabled. This makes it possible to have a quick indication on the temperature and thus the function of the device 1 or, at occasions, the concentration level etc. prevailing inside channel 7.
A second embodiment of a sensor unit 11 is shown in fig 3a. In accordance with connecting parts described in the above- mentioned WO document, the sensor unit is provided with snap wings 14, and pressing portions 15 on holding means 17. Further, locking elements or shoulders 18 are used for positioning the sensor unit 11 on a bloodstream access device 1 (Fig. 1) .
An oblong sensor element 16 is positioned centrally and with an acute angle with respect to a longitudinal axis of the sensor unit 11. At the sides of the sensor element 16, there are indicated two areas 19 which may be coloured in scales so as to provide easy indication of flow, temperature, concentration etc. etc.
Fig. 3b shows the sensor unit 11 in a longitudinal section wherein the curved sensor element 16 contributes to limit a channel 13, which corresponds to the channel 7 of the sensor unit 5 in Fig. 2a.
The invention may be modified further and for example the sensor units 5 and 11, which in practice are lid members for co-operation with the bloodstream access device, may be connected to outside equipment for indicating sensed temperature, flow concentration etc. This is indicated in fig 4, which shows a system including an inventive sensor unit in respect of a human. In this case the lid member may be connected, for example over an electric wire 21 or wireless, with a wrist carried indicator 22 resembling a wrist-watch.
It is also possible to combine the sensor unit with other kinds of equipment. For example in case of the sensor unit includes a sensor element for sensing blood glucose level, an inventive sensor unit may be connected to an insulin pump 23 for introducing insulin into the body of the patient. A simple external device may be a warning indicator such as a buzzer, a beeper or a lamp, indicating malfunction or parameter levels below a predetermined value.
As examples, blood temperature, blood flow, blood-pressure, level of biochemical substances such as glucose, insulin, urea may be subject to being sensed by adapted sensor elements of a sensor unit according to the invention. Further modifications may include other per se known sensor elements; use in connection with other types of bloodstream access devices; and connections to other kinds of indicators and external equipment .

Claims

Claims :
1. Sensor unit (5; 11) including at least one sensor element (8,-16) for sensing a blood related parameter in a bloodstream of a human or an animal, characterized in
that the sensor unit (5; 11) includes a lid member for a main body of a bloodstream access device (1) which includes connecting elements (2,2') for connection to an artery and a vein of the human or the animal,
that the sensor unit comprises a channel (7; 13) for allowing a continuous blood flow passing between an artery side and a vein side of the bloodstream access device (1) , and
that the sensor element (s) (8; 16) is (are) positioned for sensing the blood related parameter(s) in the channel (7;13) .
2. Sensor unit according to claim 1, characterized in that it includes a parameter level indicator.
3. Sensor unit according to claim 1, characterized in that it includes means (21) for transmitting parameter related signals to an external receiver (22) .
4. Sensor unit according to claim 1, 2 or3 , characterized in that the sensor element (8; 16) is a liquid crystal sensor.
5. Sensor unit according to any one of the claims 1 - 4, characterized in that the sensor element (8,-16) is a sensor for one parameter in the group: blood temperature, blood flow, blood-pressure, level of biochemical substances such as glucose, insulin, urea.
6. Method for monitoring the function of a bloodstream access device, characterized by sensing blood temperature in a channel (7; 13) of a lid member for a main body of a bloodstream access device (1) which channel allows a continuous blood flow passing between an artery side and a vein side of the bloodstream access device ( 1 ) , and
using the sensed value as an indication of the blood flow through the bloodstream access device.
7. Blood parameter sensor system, characterized in that it includes a bloodstream access device (1) and a sensor unit (5; 11) according to any of the claims 1 - 5.
8. System according to claim 7, characterized in that it includes a feed-back device (23) for administration of a substance into the human or the animal as a response to a sensed parameter level .
9. System according to claim 8, characterized in that the feed-back device (23) includes a controlled pump for the substance.
PCT/SE2003/000784 2002-05-17 2003-05-14 Sensor unit and method for sensing a blood related parameter and system including such a sensor unit WO2003096903A1 (en)

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DE60323633T DE60323633D1 (en) 2002-05-17 2003-05-14 MEASURING SENSOR UNIT AND METHOD FOR MEASURING A BLOOD RELEVANT PARAMETER AND SYSTEM WITH SUCH A MEASURING SENSOR UNIT
US10/514,635 US20050131305A1 (en) 2002-05-17 2003-05-14 Sensor unit and method for sensing a blood related parameter and system including such a sensor unit
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AU2003232703A1 (en) 2003-12-02
US20050131305A1 (en) 2005-06-16
EP1509131A1 (en) 2005-03-02
ATE408373T1 (en) 2008-10-15
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DE60323633D1 (en) 2008-10-30
SE0201497D0 (en) 2002-05-17
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